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Goode Surgical, Inc.

FDA Regulatory Profile

Goode Surgical, Inc. has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Goode Surgical, Inc." and its spelling variant "Goode Surgical".

Latest inspection: May 7, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	9	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Goode Surgical, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	2	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

9 inspections from Jun 24, 2009 to May 7, 2025.

Date	Site	Product	Classification	FEI
May 7, 2025	Las Vegas, NV	Biologics	No Action Indicated (NAI)	3009195368
Feb 11, 2020	Phoenix, AZ	Biologics	No Action Indicated (NAI)	3006541141
Dec 4, 2017	Las Vegas, NV	Biologics	No Action Indicated (NAI)	3009195368
Mar 15, 2017	Phoenix, AZ	Biologics	No Action Indicated (NAI)	3006541141
Apr 7, 2016	Las Vegas, NV	Biologics	No Action Indicated (NAI)	3009195368
Jun 15, 2015	Phoenix, AZ	Biologics	No Action Indicated (NAI)	3006541141
Sep 9, 2014	Las Vegas, NV	Biologics	No Action Indicated (NAI)	3009195368
Nov 2, 2011	Phoenix, AZ	Biologics	No Action Indicated (NAI)	3006541141
Jun 24, 2009	Phoenix, AZ	Biologics	No Action Indicated (NAI)	3006541141

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3009195368	Las Vegas, NV	4	May 7, 2025
FEI 3006541141	Phoenix, AZ	5	Feb 11, 2020

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